Sheet for closing aseptic containers, aseptic container comprising said sheet, and equipment and method for obtaining said container

ABSTRACT

The present invention relates to a closing sheet for aseptic containers, aseptic container comprising said sheet, equipment and method for obtaining said container. The closing sheet comprises a first sheet ( 7 ) configured to be traversed by ethylene oxide and a second sheet ( 8 ) of impermeable material. The first sheet ( 7 ) is obtained from a first reel ( 7′ ) of film of material that is permeable to ethylene oxide and the second sheet ( 8 ) is obtained from a second reel ( 8′ ) of film of impermeable material. The first sheet ( 7 ) is longitudinally sealed to the second sheet ( 8 ) through a sealing line ( 18 ), thus forming a single closing sheet ( 10 ).

OBJECT OF THE INVENTION

A first aspect of the present invention relates to a closing sheet foraseptic containers, a second aspect relates to an aseptic containercomprising said closing sheet for the aseptic safety of the containedproduct, a third aspect relates to equipment for obtaining saidcontainer and finally, a fourth aspect relates to a method for obtainingthe container of the invention, being applicable in the industry ofpharmaceutical products and medical use products, in which theavailability of products such as instruments, garments or dressings thatare properly sterilized and free of microorganisms until the time theyare used, is required.

BACKGROUND OF THE INVENTION

In the industry of pharmaceutical and medical use products, it isnecessary to have containers ensuring suitable asepsis and hygieneconditions for the products that they contain until the time they areused, usually by healthcare personnel and in some cases by the actualpatient.

This type of container comprises a body of impermeable material, whichis obtained from a reel of multilayer film (for example, of polyesterand/or polyurethane), in which housings suitable for the product to becontained are continuously configured, (for example by means ofthermoforming, thermoforming with suction, molding, etc) and a closingsheet which is sealed on the edges of the body of impermeable material,the mentioned closing sheet comprising a material that is permeable toethylene oxide. The closing sheet is obtained from a continuously fedreel of film which is arranged on the housings formed from a reel ofmultilayer film and after it is sealed, the unitary containers are cutor separated.

The sterilization of this type of container is carried out once thecontainer is hermetically sealed by means of the closing sheet,containing the object or product to be sterilized. Said sterilization iscarried out by inserting the container in an asepsis chamber, which ishermetically closed, a bath of the container being carried out by meansof the diffusion of ethylene oxide (normally mixed with other gases) ingaseous state. By means of said bath, ethylene oxide penetrates into thecontainer through the sheet that is permeable thereto and sterilizes itsinterior, as well as the product contained in the container, eliminatingpossible microbes and spores.

The atmosphere of the chamber is then stabilized so that the applicationof ethylene oxide acts suitably for a certain time, and the gas is thenextracted or evacuated from the chamber, for example by means of gasabsorbers or exhausters, a completely impermeable container the interiorof which is suitably sterilized thus being obtained.

The previously described sterilization process is common to many typesof aseptic containers for containing medical or pharmaceutical productsor objects.

In the containers described in the previous paragraph, as has beenindicated, the material that is permeable to ethylene oxide is in theclosing sheet of the container, there being currently two types ofcontainers, according to the arrangement of said permeable material andthe process for obtaining the closing sheet.

On one hand, there are containers in which the closing sheet is obtaineddirectly from a reel of material that is permeable to ethylene oxide,such that the entire surface of the closing sheet is made of materialthat is permeable to ethylene oxide, which involves an unnecessary costincrease of the container due to the fact that the cost of said materialis much higher than that of the multilayer material in which the body ofthe container is manufactured.

On the other hand, there are containers in which both the body and theclosing sheet are manufactured from a reel of multilayer film (forexample of polyester and polypropylene), an inner portion of the closingsheet being cut once the closing sheet has been sealed on thecorresponding body of the container, the material that is permeable toethylene oxide being arranged in the space freed up by said cut, bymeans of heat sealing.

The aseptic container AMCOR®, corresponding to the multinational companyDUPONT®, can be mentioned as a commercial example of this type ofcontainer, which container comprises the use of TYBET® sheets ofmaterial that is permeable to ethylene oxide, which are used to handle alarge variety of sterile products in the medical and pharmaceuticalsector, achieving a suitable protection of the contained product, suchas for example gowns or any type of disposable medical garment, thusincreasing the life and the hygienic conditions of the content of thecontainer during its packaged period.

The problem of this type of container is that it requires the use of anexpensive and complex machine and it furthermore increases the waste ofmultilayer film.

DESCRIPTION OF THE INVENTION

A first aspect of the present invention relates to a closing sheet foraseptic containers, for sealing an interior of said containers whichcontain objects for medical and/or pharmaceutical use. The closing sheetis obtained from a first reel of film of material that is permeable toethylene oxide and from a second reel of film of impermeable material,both of which are continuously fed, which are longitudinally heat sealedin a sealing line. The closing sheet will be joined, by heat sealing, tothe body of the corresponding container through perimetric edges.

The closing sheet, once it has been sealed on the correspondingcontainer and cut to individualize the container, is formed by a firstsheet configured to be traversed by ethylene oxide and a second sheet ofimpermeable material, a first edge of the first sheet being overlappedwith a first edge of the second sheet, forming the mentioned sealingline, the closing sheet comprising perimetric edges formed by a secondedge of the first sheet and a second edge of the second sheet.

The sealing line can be straight, circular, crooked, etc., and theclosing sheet can have a surface coinciding with a parallelogram, whichcan be elliptical, circular, etc.

The closing sheet can have a notch to facilitate its opening, or canincorporate (zipper type) opening and closing means which allow re-usingthe container.

The second sheet can be formed from a multilayer film, for example ofpolyester and/or polypropylene.

The closing sheet can comprise a printed mark for identifying thecontainer.

A second aspect of the invention relates to an aseptic containercomprising a closing sheet like the one described above for containingsterilized objects for medical and/or pharmaceutical use, comprising abody of impermeable material, with the usual barrier characteristics andwith a high micronage, defining a housing configured to contain anobject, preferably a unitary container, free of microorganisms andspores (in the suitable percentage to obtain asepsis).

According to the invention, the closing sheet is configured to seal thehousing defined by the body of the container, the mentioned perimetricedges of said closing sheet being heat sealed to outer edges of the body(1) of the container in its entire perimeter, and said perimetric edgesbeing formed by second perimetric edges corresponding to the first sheetand by second perimetric edges corresponding to the second sheet.

The possibility is contemplated that the body of the container isconfigured to be obtainable from a multilayer sheet (for example ofpolyester and/or polypropylene) of plastic, the housing configured toobtain the object being defined by means of thermoforming saidmultilayer sheet, by means of thermoforming with suction or by molding.It is also possible for the body of the container to be pre-manufacturedin an independent machine for its insertion in the automatic equipmentmaking the container, by means of the closing the mentioned body withthe closing sheet obtained.

The second sheet is made of a material enabling its welding to the bodyof the container, (for example, with a layer of polyethylene forsealing) and will preferably be made of the same material as the body.

The surface of the first sheet is configured to allow a passage of anamount of ethylene oxide sufficient to sterilize the housing and theobject contained in the container.

The possibility is contemplated that the aseptic container compriseseasy opening means existing in the containers of the state of the artconfigured to allow a removal of the closing sheet by a user withoutadditional means for opening the container.

The aseptic container can comprise an identifying mark for identifyingthe object contained in the container. It is also provided that theidentifying mark is made in the container and in the closing sheet,depending on the technology used for the printing (ink, laser, etc.) andon the nature and characteristics of the material of the body of thecontainer and of the closing sheet.

The problems of this type of closing sheet, formed by two sheets ofdifferent material, is that the impermeable material and the materialthat is permeable to ethylene oxide have a different behavior withregard to their melting point and to their deformation due to stress,therefore, in the event of heat welding at a suitable temperature forthe impermeable material, the part of material that is permeable toethylene oxide is not correctly welded, with the appearance of wrinkles,whereas in the event that the temperature is the suitable one for heatwelding the permeable material, there is then an excessive deformationof the impermeable material, whereby a correct sealing of the containeris not achieved.

The closing sheet for aseptic containers, the aseptic containercomprising said sheet, the equipment and the method for obtaining saidcontainer proposed by the invention allows solving the problems setforth above, in the line of heat sealing the closing sheet to the bodyof the container, taking into consideration the melting points of eachmaterial.

The sealing is thus carried out by means of two sealing molds which sealat different temperature and pressure, and therefore undergo differentdeformations, each temperature being adapted to the nature of thematerial to be sealed. In the event of using materials of similarsealing temperatures, a single sealing mold could be used.

Since the elasticity of the impermeable material is greater than thematerial that is permeable to ethylene oxide, for the purpose ofpreventing deformations in the packaging process and preventing theclosing sheet from being wrinkled or deformed, before heat sealing theclosing sheet to the body of the container, making weld points (one weldpoint per container) between a part of the second sheet of impermeablematerial of the closing sheet and the body of the container iscontemplated, the deformation of the closing sheet thus being prevented.

A third aspect of the invention relates to equipment for obtaining anaseptic container described above, comprising:

-   -   a frame,    -   a lower reel comprising a film of impermeable material        configured to obtain a containing body of the container,    -   a plurality of clamps configured to hold two opposite perimetric        edges of a sheet of the material of the lower reel.    -   A forming mold configured to thermoform a housing in the        impermeable material which will form the body of the container.

Likewise, the equipment can comprises at lest one vacuum pump configuredto perform vacuum in a face of the body opposite to the closing sheet.

The equipment also comprises:

-   -   a first reel comprising a film of material that is permeable to        ethylene oxide,    -   a second reel comprising a film of impermeable material,    -   sealing jaws configured to heat seal a longitudinal edge of the        film of permeable material of the first reel to a longitudinal        edge of the film of impermeable material of the second reel,        through a sealing line, to form a closing sheet comprising a        first sheet of material that is permeable to ethylene oxide and        a second sheet of impermeable material, the first and the second        sheet being joined through a first edge forming the mentioned        sealing line    -   a welding device configured to heat weld the film of impermeable        material of the second reel, in a plurality of weld points (one        point per container), to the film of impermeable material        configured to obtain a containing body of the container, in an        outer edge of the mentioned body of the container, to prevent        ripples and wrinkles in the film,    -   a first sealing mold configured to heat seal the first sheet to        the outer edges of the body through a first area at a first        sealing temperature,    -   a second sealing mold configured to heat seal the second sheet        to the outer edges of the body through a second area at a second        sealing temperature different from the first sealing        temperature.

The equipment can comprise a side cutting module configured to cutsurplus sides of the closed container, a longitudinal cutting moduleconfigured to cut surplus longitudinal edges of the closed container, adevice configured to collect the surplus of film of the process and atleast one conveyor belt configured to move the obtained containers inthe equipment.

The first sealing mold is configured to heat seal the second edges ofthe first sheet to outer edges of the body of the container and thesecond sealing mold is configured to heat seal the perimetric edges ofthe closing sheet to the outer edges of the body of the container. Inthe second sealing mold, the second edges of the second sheet are heatsealed and the second edges of the first sheet are heat sealed again.The possibility is contemplated that the second sealing mold can onlyheat seal the second edges of the second sheet. This heat sealing couldbe carried out simultaneously or sequentially with the heat sealing ofthe first sealing mold. When the sealing temperatures and the propertiesof deformation due to stress are similar for the first sheet and thesecond sheet, the heat sealing can be carried out in a single sealingmold.

Finally, a fourth aspect of the invention relates to a method forobtaining an aseptic container described above with equipment like thatdescribed above, comprising the following steps:

-   -   holding with a plurality of clamps two opposite perimetric edges        of a film of impermeable material comprised in a lower reel,    -   thermoforming a housing in the sheet of impermeable material        forming a body,    -   arranging an object to be packaged in the housing,    -   heat sealing by means of sealing jaws a longitudinal edge of a        film of material that is permeable to ethylene oxide, comprised        in a first reel, to a longitudinal edge of a film of impermeable        material, comprised in a second reel, through a sealing line,        forming a closing sheet comprising a first sheet of material        that is permeable to ethylene oxide and a second sheet of        impermeable material, the first and the second sheet being        joined by the overlapping of a first edge of the first and        second sheets forming the mentioned sealing line    -   heat welding in a plurality of weld points (one point per        container) the film of impermeable material of the second reel        with the film of impermeable material of the lower reel, in an        outer edge of the body of the container,    -   heat sealing, in a first sealing mold, a second edge of the        first sheet to the outer edges of the body of the container,        through a first area, at a first sealing temperature,    -   heat sealing, in a second sealing mold, the perimetric edges of        the closing sheet to the outer edges of the body of the        container at a second sealing temperature different from the        first sealing temperature, comprising the heat sealing of the        second edge of the second sheet and the heat sealing (it is heat        sealed again) of the second edge of the first sheet. The heat        sealing in the second sealing mold can comprise only the heat        sealing of the second edge of the second sheet to the outer        edges of the body of the container, through a second area, at a        second sealing temperature different from the first sealing        temperature.

It is contemplated as a possibility that the method comprises heatsealing the first sheet to the outer edges and the second sheet to theouter edges simultaneously.

Likewise, after heat sealing the closing sheet to the body, the methodcan comprise the following steps:

-   -   cutting surplus sides of the container in a side cutting module,    -   cutting surplus longitudinal edges of the container in a        longitudinal cutting module,    -   collecting the surplus of the impermeable film and of the film        that is permeable to ethylene oxide

Finally, the aseptic container can be marked with an identifying markfor identifying the object contained in the container.

The container can furthermore be obtained, manufactured in automaticpackaging lines or equipment existing in the state of the art, allowinga quick and efficient adjustment of the production.

The container obviously complies with its function of keeping the objectcontained therein in hermetic conditions.

The container and the method proposed by the invention are cheaper thancurrent containers and methods due to the fact that a smaller amount ofmaterial that is permeable to ethylene oxide is used, the cost of whichis much higher than the rest of the material of the container.

The equipment for obtaining the container is simpler than the equipmentnecessary for manufacturing the containers of the state of the art whichhave a window of permeable material in the closing sheet, having in turna higher production capacity, further allowing a suitable control of theformation of wrinkles and deformation in the lid of the container.

Finally, the equipment allows obtaining different container formats witha minimal number of changes, in molds and jaws, not being restricted tofixed container dimensions, all of this in different types of automaticpackaging equipment by means of thermoforming and heat sealing.

DESCRIPTION OF THE DRAWINGS

To complement the description which is being made and with the aim ofaiding to better understand the features of the invention according to apreferred practical embodiment thereof, a set of drawings is attached asan integral part said description in which the following has beendepicted with an illustrative and non-limiting character:

FIG. 1 shows a perspective view of the aseptic container object of theinvention.

FIG. 2 shows a section according to line AA of the container of theprevious figure.

FIG. 3 shows a perspective view of the aseptic container object of theinvention, in which the three sealings required to obtain it have beenindicated approximately.

FIG. 4 shows a schematic perspective view of a part of the equipmentcomprising the film feed reels, depicting the longitudinal heat sealingphase thereof for obtaining the closing sheet of the invention.

FIG. 5 shows a schematic perspective view of the first sealing moldcomprised by the equipment of the invention.

FIG. 6 schematic perspective view of the second sealing mold comprisedby the equipment of the invention.

FIG. 8 shows an elevational view of the equipment for obtaining asepticcontainers proposed by the invention.

PREFERRED EMBODIMENT OF THE INVENTION

In view of the indicated figures, it can be observed how in one of thepossible embodiments of the invention, a first aspect of the inventionrelates to a closing sheet for aseptic containers, for sealing aninterior of said containers which contain objects for medical and/orpharmaceutical use, comprising a first sheet (7) configured to betraversed by ethylene oxide and a second sheet (8) of impermeablematerial.

According to the invention, the first sheet (7) is obtained from a reel(7′) and the second sheet (8) is obtained from a second reel (8′), beinglongitudinally joined, as is observed in FIG. 4, through a sealing line(18).

As is observed in FIGS. 1 and 2, in the heat sealing line (18) the sheet(7) is overlapped with the sheet (8) through a first edge (7″) and (8″)of each of the sheets (7) and (8) respectively.

The sealing line (18) is preferably straight, and furthermore theclosing sheet (10) has a quadrangular surface and the sealing line (18)is parallel to one of the sides thereof, as is depicted in the attachedfigures.

In other embodiments, not shown, the sealing line (18) can be curved,wavy or crooked and the closing sheet (10) can have a rectangular, ovalor circular surface, depending on the shape of the container.

The second sheet (8) is preferably made of multilayer film, for example,polyester and/or polypropylene.

The closing sheet (10) can comprise a printed mark for identifying saidclosing sheet (10).

A second aspect of the invention relates to an aseptic containercomprising a closing sheet (10) described above for containingsterilized objects for medical and/or pharmaceutical use.

The container comprises a body (1) of impermeable material, with theusual barrier characteristics and with a high micronage, defining ahousing (6′) configured to contain an object (6), preferably a unitcontainer, free of microorganisms.

According to the invention the closing sheet (10) is configured to sealthe housing (6′), perimetric edges of said closing sheet (10) being heatsealed to outer edges (1″) of the body (1) of the container in itsentire perimeter. The perimetric edges of the closing sheet are formedby a second edge (7′″) and (8′″), of each of the sheets (7) and (8)respectively.

On the other hand, the body (1) of the container is configured to beobtainable from a multilayer film, for example of polyester and/orpolypropylene, the housing (6′) being defined by means of forming saidbody (1), for example, by thermopressure, blowing or by molding.

The second sheet (8) is preferably made of a material compatible forwelding to the body (1), comprising for example a layer of polyethylenefor sealing.

The second sheet (8) can be made of the same material as the body (1).

The surface of the first sheet (7) is configured to allow a passage ofan amount of ethylene oxide sufficient to sterilize the housing (6′) andthe object (6) contained in the container.

The possibility is contemplated that the aseptic container compriseseasy opening means existing in the containers of the state of the artconfigured to allow a removal of the closing sheet (10) by a userwithout additional means for opening the container.

The container can likewise comprise an identifying mark for identifyingthe object (6) contained in the container, made previously in the filmof impermeable material or during the manufacture of the container.

A third aspect of the invention relates to equipment for obtaining anaseptic container described above, comprising a frame (3), as well as alower reel (1′) comprising an impermeable material configured to obtaina body (1) of the container, a plurality of clamps (2) configured tohold two opposite perimetric edges of a sheet of the material of thelower reel (1′), a forming mold (4), which can be actuated by means ofpneumatic cylinders or mechanically (13), configured to thermoform ahousing (6′) in the body (1).

The equipment can comprise a vacuum pump (5) configured to performvacuum in a face of the body (1) opposite to the closing sheet (10).

The equipment further comprises a first reel (7′) comprising a film ofmaterial that is permeable to ethylene oxide and a second reel (8′)comprising a film of impermeable material.

The equipment comprises sealing jaws (9) configured to heat seal alongitudinal edge of the film of permeable material of the first reel toa longitudinal edge of the film of impermeable material of the secondreel, through a sealing line, to form a closing sheet (10) comprising afirst sheet (7) of material that is permeable to ethylene oxide and asecond sheet (8) of impermeable material, the first sheet (7) and thesecond sheet (8) being overlapped through a first edge (7″) and (8″),respectively, forming the mentioned sealing line (18).

The equipment also comprises a welding device (11) configured to heatweld the film of impermeable material of the second sheet (8′), in aplurality of weld points (19), to the film of impermeable materialconfigured to obtain a containing body of the container in outer edge(1″) of the body (1). The welding device (11) has been schematicallydepicted in FIG. 7.

The equipment also comprises a first sealing mold (12) configured toheat seal the first sheet (7) to the outer edges (1″) of the body (1),through a first area, at a first sealing temperature (carrying out awelding (18′) schematically depicted in FIG. 3), and a second sealingmold (12′) configured to heat seal the closing sheet (10) to the outeredges (1″) of the body (1) at a second sealing temperature differentfrom the first sealing temperature, comprising the heat sealing of thesecond edge (8′″) of the second sheet (8) and of the second edge (7′″)of the first sheet (7), carrying out a welding (18″) schematicallydepicted in FIG. 3). The first sealing mold (12) has been schematicallydepicted in FIG. 5, whereas the second sealing mold (12′) has beenschematically depicted in FIG. 6.

The second sealing mold (12′) can be configured to heat seal only thesecond edges (8′″) of the second sheet (8) to the outer edges (1″) ofthe body (1) at the mentioned second temperature. In this case, thefirst sealing mold (12) and the second sealing mold (12′) can beconfigured to simultaneously heat seal the first sheet (7) and thesecond sheet (8) to the outer edges (1″) of the body (1).

The possibility is contemplated that the equipment comprises a sidecutting module (15) configured to cut surplus sides of the closedcontainer, a longitudinal cutting module (16) configured to cut surpluslongitudinal edges of the closed container, a device (17) configured tocollect the surplus of film of the process and at least one conveyorbelt (20) configured to move the containers in the equipment.

Finally, a fourth aspect of the invention relates to a method forobtaining an aseptic container described above with equipment like thatdescribed above, comprising the following steps:

-   -   holding with a plurality of clamps (2) two opposite perimetric        edges of a film of impermeable material comprised in a lower        reel (1′),    -   thermoforming a housing (6′) in the sheet of impermeable        material forming a body (1),    -   arranging an object (6) to be packaged in the housing (6′),    -   heat sealing by means of sealing jaws (9) a longitudinal edge of        a film of material that is permeable to ethylene oxide,        comprised in a first reel (7′), to a longitudinal edge of a film        of impermeable material, comprised in a second reel (8′),        through a sealing line (18), forming a closing sheet (10)        comprising a first sheet (7) of material that is permeable to        ethylene oxide and a second sheet (8) of impermeable material,        the first sheet (7) and the second sheet (8) being overlapped        through a first edge (7″) and (8″) respectively, forming the        mentioned sealing line (18)    -   heat welding in a plurality of weld points the film of        impermeable material of the second reel (8′) with the film of        impermeable material of the lower reel (1′), in an outer edge        (1″) of the body (1) of the container,    -   heat sealing, in a first sealing mold (12), a second edge (7′″)        of the first sheet (7) to the outer edges (1″) of the body (1)        of the container, through a first area, at a first sealing        temperature,    -   heat sealing, in a second sealing mold (12′), the perimetric        edges of the closing sheet (10) to the outer edges (1″) of the        body (1) at a second sealing temperature different from the        first sealing temperature, comprising the heat sealing of a        second edge (8′″) of the second sheet (8) and of a second edge        (7′″) of the first sheet.

It is contemplated as a possibility that the method comprises heatsealing, in the second sealing mold (12′), only the second edges (8′″)of the second sheet (8) to the outer edges (1″) at the mentioned secondtemperature. The possibility is contemplated that the heat sealing inthe second mold (12′) and in the first mold (12) are carried outsimultaneously.

Likewise, after heat sealing the closing sheet (10) to the body (1), themethod can comprise the following steps:

-   -   cutting surplus sides of the container in a side cutting module        (15),    -   cutting surplus longitudinal edges of the container in a        longitudinal cutting module (16),    -   collecting the surplus of the impermeable film and of the film        that is permeable to ethylene oxide.

Finally, the aseptic container can be marked with an identifying markfor identifying the object (6) contained in the container.

In view of this description and set of figures, the person skilled inthe art can understand that the embodiments of the invention which havebeen described can be combined in multiple ways within the object of theinvention. The invention has been described according to severalpreferred embodiments thereof, but it will be evident for the personskilled in the art that multiple variations can be introduced in saidpreferred embodiments without exceeding the object of the claimedinvention.

1. Closing sheet for aseptic containers, for sealing an interior of saidcontainers which contain objects for medical and/or pharmaceutical use,comprising a first sheet (7) configured to be traversed by ethyleneoxide and a second sheet (8) of impermeable material, wherein the firstsheet (7) is obtained from a first reel (7′) of film of material that ispermeable to ethylene oxide and the second sheet (8) is obtained from asecond reel (8′) of film of impermeable material, and in that the firstsheet (7) is longitudinally sealed to the second sheet (8) through astraight sealing line (18), thus forming a single closing sheet (10),wherein said sealing line (18) is formed by the overlapping of a firstedge (7″) of the first sheet (7) and a first edge (8″) of the secondsheet (8) and in that the perimetric edges of the closing sheet (10) areformed by a second edge (7″) of the first sheet (7) and a second edge(8′″) of the second sheet (8).
 2. Sheet according to claim 1, whereinthe second sheet (8) is a multilayer film of polyester and/orpolypropylene.
 3. Sheet according to claim 1, characterized in thatwherein the closing sheet (10) comprises a printed mark for identifyingsaid closing sheet (10).
 4. Aseptic container comprising: a closingsheet (10) for containing objects for medical and/or pharmaceutical use,the closing sheet comprising a first sheet (7) configured to betraversed by ethylene oxide and a second sheet (8) of impermeablematerial, the first sheet (7) is obtained from a first reel (7′) of filmof material that is permeable to ethylene oxide and the second sheet (8)is obtained from a second reel (8′) of film of impermeable material, andin that the first sheet (7) is longitudinally sealed to the second sheet(8) through a straight sealing line (18), thus forming a single closingsheet (10), wherein said sealing line (18) is formed by the overlappingof a first edge (7″) of the first sheet (7) and a first edge (8″) of thesecond sheet (8) and in that the perimetric edges of the closing sheet(10) are formed by a second edge (7′″) of the first sheet (7) and asecond edge (8′″) of the second sheet (8); wherein thecontainer-comprises a body (1) of impermeable material defining ahousing (6′) configured to contain an object (6), comprising a closingsheet (10) configured to seal the housing (6′), the perimetric edges ofsaid closing sheet (10) being heat sealed to outer edges (1″) of thebody (1) of the container in its entire perimeter, wherein the body (1)of the container is configured to be obtained from a sheet of multilayerfilm of polyester and/or polypropylene, the housing (6′) being definedby means of thermoforming or molding of said body (1).
 5. Asepticcontainer according claim 4, wherein the second sheet (8) is made of amaterial enabling its welding to the body (1) of the container. 6.Aseptic container according to claim 5, wherein the second sheet (8)comprises a layer of polyethylene for sealing.
 7. Aseptic containeraccording to claim 5, wherein the second sheet (8) is of the samematerial as the body (1) of the container.
 8. Aseptic containeraccording to claim 4, wherein the surface of the first sheet (7) isconfigured to allow a passage of an amount of ethylene oxide sufficientto sterilize the housing (6′) and the object (6) contained in thecontainer.
 9. Aseptic container according to claim 4, wherein thecontainer it comprises easy opening means configured to allow a removalof the closing sheet (10) by a user without additional means for openingthe container.
 10. Aseptic container according to claim 4, wherein thecontainer comprises an identifying mark for identifying the object (6)contained in the container.
 11. Equipment for making an asepticcontainer, the container comprising a closing sheet and a body (1) ofimpermeable material defining a housing (6′) configured to contain anobject (6) comprising a closing sheet (10) configured to seal thehousing (6′), the perimetric edges of said closing sheet (10) being heatsealed to outer edges (1″) of the body (1) of the container in itsentire perimeter, wherein the body (1) of the container is configured tobe obtained from a sheet of multilayer film of polyester and/orpolypropylene the housing (6′) being defined by means of thermoformingor molding of said body (1), the equipment comprising: a frame (3): alower reel (1′) comprising a film of impermeable material configured toobtain a body (1) of the container, a plurality of clamps (2) configuredto hold two opposite perimetric edges of the film of impermeablematerial of the lower reel (1′), a forming mold (4) configured tothermoform a housing (6′) in the reel of film of impermeable materialwhich will form a body (1), a first reel (7′) comprising a film ofmaterial that is permeable to ethylene oxide, a second reel (8′)comprising a film of an impermeable material, sealing jaws (9)configured to heat seal a longitudinal edge of the film of permeablematerial of the first reel to a longitudinal edge of the film ofimpermeable material of the second reel, through a sealing line, to forma closing sheet (10) comprising a first sheet (7) of material that ispermeable to ethylene oxide and a second sheet (8) of impermeablematerial, the first sheet (7) and the second sheet (8) being overlappedthrough a first edge (7″) and (8″), respectively, forming the mentionedsealing line (18); a welding device (11) configured to heat weld thefilm of impermeable material of the second reel (8′), in a plurality ofweld points (19), to the film of impermeable material configured toobtain a containing body of the container in outer edge (1″) of the body(1), a first sealing mold (12) configured to heat seal a second edge(7′″) of the first sheet (7) to the outer edges (1″) of the body (1),through a first area, at a first sealing temperature, a second sealingmold (12′) configured to heat seal a second edge (8′″) of the secondsheet (8) to the outer edges (1″) of the body (1), through a secondarea, at a second sealing temperature different from the first sealingtemperature.
 12. Equipment according to claim 11, wherein the firstsealing mold (12) and the second sealing mold (12′) are configured toheat seal the first sheet (7) to the outer edges (1″) and the secondsheet (8) to the outer edges (1″) simultaneously.
 13. Equipmentaccording to claim 11, wherein the second sealing mold (12′) isconfigured to heat seal the second edge (7′″) of the first sheet (7) toouter edges (1″) of the body (1), through a first area, at the secondsealing temperature.
 14. Equipment according to claim 11, furthercomprising: a side cutting module (15) configured to cut surplus sidesof the closed container, a longitudinal cutting module (16) configuredto cut surplus longitudinal edges of the closed container, a deviceconfigured to collect the surplus of film of the process; at least oneconveyor belt (20) configured to move the obtained containers in theequipment.
 15. Method for obtaining an aseptic container, the containercomprising a closing sheet and a body (1) of impermeable materialdefining a housing (6′) configured to contain an object (6), comprisinga closing sheet (10) configured to seal the housing (6′), the perimetricedges of said closing sheet (10) being heat sealed to outer edges (1″)of the body (1) of the container in its entire perimeter, wherein thebody (1) of the container is configured to be obtained from a sheet ofmultilayer film of polyester and/or polypropylene, the housing (6′)being defined by means of thermoforming or molding of said body (1); theequipment comprising: a frame (3), a lower reel (1′) comprising a filmof impermeable material configured to obtain a body (1) of thecontainer, a plurality of clamps (2) configured to hold two oppositeperimetric edges of the film of impermeable material of the lower reel(1′), a forming mold (4) configured to thermoform a housing (6′) in thereel of film of impermeable material which will form a body (1), a firstreel (7′) comprising a film of material that is permeable to ethyleneoxide, a second reel (8′) comprising a film of an impermeable material,sealing jaws (9) configured to heat seal a longitudinal edge of the filmof permeable material of the first reel to a longitudinal edge of thefilm of impermeable material of the second reel, through a sealing line,to form a closing sheet (10) comprising a first sheet (7) of materialthat is permeable to ethylene oxide and a second sheet (8) ofimpermeable material, the first sheet (7) and the second sheet (8) beingoverlapped through a first edge (7″) and (8″), respectively, forming thementioned sealing line (18); a welding device (11) configured to heatweld the film of impermeable material of the second reel (8′), in aplurality of weld points (19), to the film of impermeable materialconfigured to obtain a containing body of the container in outer edge(1″) of the body (1), a first sealing mold (12) configured to heat seala second edge (7′″) of the first sheet (7) to the outer edges (1″) ofthe body (1), through a first area, at a first sealing temperature, asecond sealing mold (12′) configured to heat seal a second edge (8′″) ofthe second sheet (8) to the outer edges (1″) of the body (1), through asecond area, at a second sealing temperature different from the firstsealing temperature; the method comprises the following steps: holdingwith a plurality of clamps (2) two opposite perimetric edges of a filmof impermeable material comprised in a lower reel (1′), thermoforming ahousing (6′) in the sheet of impermeable material forming a body (1),arranging an object (6) to be packaged in the housing (6′), heat sealingby means of sealing jaws (9) a longitudinal edge of a film of materialthat is permeable to ethylene oxide, comprised in a first reel (7′), toa longitudinal edge of a film of impermeable material, comprised in asecond reel (8′), through a sealing line (18), forming a closing sheet(10) comprising a first sheet (7) of material that is permeable toethylene oxide and a second sheet (8) of impermeable material, the firstsheet (7) and the second sheet (8) being overlapped through a first edge(7″) and (8″), respectively, forming the mentioned sealing line (18)heat welding in a plurality of weld points the film of impermeablematerial of the second reel (8′) with the film of impermeable materialof the lower reel (1′), in an outer edge (1″) of the body (1) of thecontainer, heat sealing, in a first sealing mold (12), a second edge(7′″) of the first sheet (7) to the outer edges (1″) of the body (1) ofthe container, through a first area, at a first sealing temperature,heat sealing, in a second sealing mold (12′), a second edge (8′″) of thesecond sheet (8) to the outer edges (1″) of the body (1) of thecontainer, through a second area, at a second sealing temperaturedifferent from the first sealing temperature.
 16. Method according toclaim 15, wherein the heat sealing in the first sealing mold (12) andthe heat sealing in the second sealing mold (12′) are carried outsimultaneously.
 17. Method according to claim 15, wherein the heatsealing in the second sealing mold (12′) comprises the heat sealing ofthe second edges (7′″) of the sheet (7) to the outer edges (1″) of thebody (1) of the container, through a first area, at the second sealingtemperature.
 18. Method according to claim 15, wherein after heatsealing the closing sheet (10) to the body (1) the further steps areperformed: cutting surplus sides of the container in a side cuttingmodule (15), cutting surplus longitudinal edges of the container in alongitudinal cutting module (16), collecting the surplus of theimpermeable film and of the film that is permeable to ethylene oxide.19. Method according to claim 15, further comprising marking the asepticcontainer with an identifying mark for identifying the object (6)contained in the container.